ANTON PAAR

Anton Paar understands your need for completely traceable results and supports you with a qualification and validation package following the 4Q model which fulfills the requirements of the pharmaceutical industry: GAMP 5, GMP, 21 CFR Part 11 and USP<1058>.

Anke Barnard

Anton Paar Pharma Qualificiation

Pharma Qualification Packages by Anton Paar include much more than the standard IQ/OQ and are prepared individually for every instrument and customer.

The PQP (Pharma Qualification Package) has been created for the pharmaceutical, biotechnological, cosmetics and food industries based on pharma-relevant regulations. It covers the complete instrument-specific pharma qualification procedure according to the USP <1058> 4Q model, including a Risk Analysis, a List of Deviations, a Traceability Matrix, chapter reports for every qualification step and a 21 CFR Part 11 Check List for full FDA compliance. A Standard Operating Procedure (SOP) is added as a word file and can be used as the basis for the customer’s internal instrument SOP.

With the Pharma Qualification and Validation Package your instrument is qualified and ready for use within 1-3 days after purchase. The instrument qualification is personalized for your instrument and company. The installation is carried out by trained and certified personnel and training on the instrument is included.

The Pharma Qualification and Validation Package includes:

Risk Analysis

Design Qualification (DQ)

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Tracebility Matrix

Standard Operating Procedure (SOP)

User training

Qualified support on-site.

The package is available on a wide range of instruments including density meters, viscometers, refractometers, polarimeters, rheometers, microwaves and many more.